Guidance for Outline Stage BMC: DPFS Applicants

Guidance for Outline Stage BMC: DPFS Applicants

Contents Page Oversight and Reporting... 2 Project Management... 2 Intellectual Property Management and Exploitation... 2 How to apply... 3 Outline Applications... 3 Outline Application Assessment Criteria... 3 Using the Joint-electronic Submission System... 8 Contacts... 9 Disclaimer; The information contained in this document is additional specific guidance for BMC: DPFS applicants and should be used in conjunction with other MRC sources of information when preparing your application, for example: Biomedical Catalyst: DPFS webpage MRC Applicants Handbook details on eligibility, costings, responsibilities etc.; MRC Industry Collaboration Agreement (MICA) relevant to industrial collaborations; Je-S Help for information or queries related to use of the Je-S System. Please ensure you have downloaded the latest version of this document via the BMC: DPFS webpage. Please note that sharing information and knowledge about MRC s research grants is central to the MRC s mission. The following details on successful BMC: DPFS applications will be made available through the Research Portfolio Search on the MRC website: Project Title Technical Summary Lay summary Grant holders Host institution Value and duration of award Version 6 October 2015 Page 1

Oversight and Reporting Project Management To ensure effective delivery, successful applicants will be required to establish appropriate project management systems to oversee any BMC: DPFS project. At the start of the project the Principal Investigator will be required to establish a project management group (PMG). The PMG, which will be accountable to its host institution, will direct the project and report to the MRC on a regular basis. Applicants will be required to appoint a project manager with responsibility for the management and co-ordination of day-to-day activities and for integrating these with any out-sourced service provision. Costs to support a dedicated project manager are eligible. For pre-clinical projects MRC would typically expect that project manager involvement to be no more than 25% FTE; for clinical projects no more than 50% FTE. During the period of BMC: DPFS support, the PMG will be required to submit to MRC Quarterly, Milestone and End Reports. If a milestone is at risk of not being met, the PMG should submit a request for change to the MRC. Projects that show negative results at milestones, or which fail to meet milestones, will be terminated, unless a compelling request for change has been submitted, and the concept has a high priority. Intellectual Property Management and Exploitation Intellectual property generated in the course of a BMC: DPFS project will be owned by the host institute, who will have the right to manage and exploit the project intellectual property. The MRC wishes, however, to assure itself that host universities are able to manage and exploit effectively the intellectual property generated from MRC-funded research. This is particularly important in the case of the BMC: DPFS, as projects supported by the scheme will likely require further development in order to meet their clinical aims. To support this further development, intellectual property will need to be appropriately managed and strategies adopted that are able to identify suitable partners and partnership terms that optimise the potential for the project to meet its clinical goals. During the period of BMC: DPFS support, the PMG will be required to prepare an intellectual property report as part of its Milestone and End Reports. Following the end of BMC: DPFS support, the Principal Investigator will be responsible for submitting an annual intellectual property report for up to 3 years. Page 2

How to apply Section contents: How to apply... 2 Outline Applications... 3 Outline Application Assessment Criteria... 3 Using the Joint-electronic Submission System... 8 Oversight... 2 Project Management... 2 Intellectual Property Management and Exploitation... 2 Contacts... 9 The following paragraphs set out the process for submitting an Outline BMC: DPFS application Outline Applications BMC: DPFS applicants must first submit an outline BMC: DPFS application. Successful outline applicants will be invited to submit a full application. The purpose of the outline application is to ascertain whether the projects aims, its rationale and deliverability are appropriate for consideration by scheme. To submit an outline application, the applicant must complete the BMC: DPFS Outline Case for Support Form and submit this as a PDF via the Je-S website. Note that applicants seeking funding for hit to lead and lead optimisation projects must additionally complete the Small Molecule Supplementary Information form. This form should be uploaded to Je-S under document type Supporting Data. Outline Application Assessment Criteria The BMC: DPFS Panel will consider outline applications against the criteria below. Panel decisions at outline stage include; Invite, Reject or Positive Feedback (a decline waiving the 12 month moratorium on re-submission). At full stage your application will be scored and ranked using the MRC scoring system as detailed in the reviewer s handbook. Please note that the decisions of the BMC: DPFS Panel will not be open to appeal and that the MRC reserves the right to amend the application process. Need Does the identified need exist? Would meeting this need significantly reduce disease burden and/or provide a valuable commercial opportunity and/or alleviate an important development bottleneck? If the need is not significant now, will it become so in the future? Is the need met or unmet. If unmet, will it likely be unmet at the time that the proposed solution is in place? Has the applicant identified the key competing solutions and their status or are you aware of other similar or complementary research underway elsewhere? Has the applicant identified the key competitive advantages of their proposed solution? How likely is it that the proposed solution, if achieved, would be widely adopted? Rationale Is there a good medical/scientific rationale for the project? Page 3

Is there a reasonable body of evidence to support the proposed rationale? Deliverability Objectives: o If successful, will the proposal make a significant contribution to meeting the identified need? o If successful, will it achieve an endpoint that has a reasonable chance of attracting any required additional investment? o Are downstream development hurdles surmountable? Plan: o Does the plan propose reasonable go/no-go milestones to judge progression? o Is the project appropriately statistically powered? o Are the preliminary budgets and schedule to reach the milestones appropriate? o What is the likelihood of the project meeting its milestones? o Given the project s risk and its potential benefits, does the plan offer good value for money? Assets: o Has the team identified and secured reasonable access to necessary resources/skills? Note that not all collaborations/out-sourcing agreements need be in place at the outline application stage o Has the individual or group established a high quality track record in the field? o Are the applicants well placed to deliver the work/ o Do the applicants have the necessary project management experience to deliver the plan? Intellectual Property Does the proposal have an appropriate intellectual property strategy: o Background Does the team have access to necessary background intellectual property? If not, are the applicant s arguments for how they will access required background intellectual property persuasive? o Foreground Is the intellectual property generated in the course of the project likely to be protectable (i.e. will it be novel, non-obvious and useable)? Will the proposed management and exploitation strategy maximize the likelihood that the project will be able to access any required downstream funding to enable the project to meet its identified need? Completing the BMC: DPFS Outline Case for Support Form The BMC: DPFS Outline Case for Support Form consists of eight sections. Use the tab key to move between cells in the form. Cells that are greyed out do not need to be filled in, since these are automatically calculated from cells elsewhere in the form. The form is expected to be completed in partnership with your Institution s Technology Transfer Office (TTO), or equivalent, and failure to do so may prejudice your application. A contact at your Institution s TTO, or equivalent, will be required for the Outline Case for Support Form The principal investigator will normally be expected to take the lead on defining the need that the proposal seeks to address and the proposed solution for this need, the project s rationale and the project plan The TTO will normally be expected to take the lead on assessing the competitive environment and intellectual property strategy Page 4

Selection will be very competitive and TTOs should maximise their institution s chances of success by selecting only those projects most suitable for BMC: DPFS support. The TTO will be expected to provide support to successful applicants in managing and exploiting intellectual property generated over the course of the project. Section 1: Project Summary 1.1 Title: Please provide a concise title for your proposal. This title should be the same as the project title of your Je-S submission. 1.2 Technical Summary: Please provide a summary of the need you are seeking to address, your proposed solution, the rationale for why your proposed solution is likely to meet the targeted need and your development plan. This technical summary should be the same as the technical summary of your Je-S submission. Both the title and technical summary should be non-confidential, as they will be used, if you are successful at the outline stage, when approaching candidate referees to review the full proposal. 1.3 Project Duration and Cost: Please enter the proposed project start date. This date should be the same as the proposed start date in your Je-S submission. The proposed duration of award, project fec, estimated MRC contribution and project partner contribution are calculated from duration and cost inputs you are required to enter later in the form. Section 2: Investigator Details Please refer to the MRC applicant s handbook for further information regarding people and organisations named on the grant 2.1 Principal Investigator [same as Je-S Principal Investigator] 2.2 Co-Investigators [same as Je-S Co-Investigators] 2.3 Industrial Project Partners [Project Partners in Je-S] Individuals from collaborating partner Industrial Organisations who would be contributing financially or intellectually to the project (i.e. not from organisations providing services on a contracted or outsourced basis). 2.4 Non-Industrial Project Partners (Collaborators) [Project Partners in Je-S] Individuals from collaborating non-industrial organisations who would be contributing financially or intellectually to the project, e.g. investigators from partner Universities providing materials and intellectual input but not requesting funds. 2.5 Subcontractors Section 3: Host Institute TTO Contact 3.1 Host Institute TTO Contact: As the MRC would normally expect the host institute TTO to assist in the preparation of a BMC: DPFS Application and to play an active role in maintaining and exploiting intellectual property generated by successful applications, the MRC asks for the contact details for a relevant member of the host institute s TTO team who should also sign the TTO s letter of support. Section 4: Need No specific guidance refer to the full application assessment criteria outlined above. Page 5

Section 5: Rationale Please provide relevant references in section 5.2 and cite elsewhere within the document as applicable. Note that up to two pages of supporting data can be uploaded as a supplementary document and can be referred to here. Applicants seeking funding for hit to lead and lead optimisation must also complete the Small Molecule Supplementary Information form and upload as a separate attachment. Section 6: Deliverability 6.3 How will the project achieve its objectives? Summarise the project workplan including two-three key progression milestones (one being the project end). For each milestone please set out the success criteria that will be used to ascertain whether the milestone has been met. For clinical studies, this should include a summary of (1) study design, (2) study participants, (3) study endpoints, (4) dose, (5) anticipated effect size and (6) analysis plans (max 800 words) Milestone success criteria should be SMART (ie quantifiable) and detail any Go/No go criteria (failure to meet which will result in early termination of the project). For all projects, it is advisable to structure the project so that the critical question(s) are addressed as early as possible in the plan. For the final milestone, the criteria should reflect outcomes that would represent successful prosecution of the project and be reflective of the data that will enable onward prosecution of exploitation of the project (covered in question 6.6). 6.4 Identify and justify the skills and resources needed to deliver the plan. Are these resources secured/available? Outline personal, equipment, costs etc. required to conduct the project detailed in section 6.3. In relation to named grant applicants, see guidance on 6.5 (below). For pre-clinical projects, particularly those transitioning to clinical studies, it is generally advisable for clinical colleagues to be involved (albeit with limited or no request for support of their time). 6.5 How will the project be managed and what experience does the team have of managing similar projects? How will the project be managed and what experience does the team have of conducting and managing similar projects? Each of the investigators C.V.s must be attached to Je-S (see the Attachments section below). Please elaborate on why the group is well qualified to conduct and manage the proposed project and how the roles of individual team members reflect their experience. 6.6 Following the end of the grant award, how will the project be sustained to enable it to meet its ultimate aims (i.e. what is your exit strategy)? What sources of subsequent funding/potential partners are potentially available to you? What criteria will need to be met in order to access these funds/partnerships and how will the planned programme of work help to meet these criteria? If your application includes or involves an industrial partner outline what role they will have, if any, in exploitation of the project following the end of grant funding. Section 7: Intellectual Property Page 6

Note that the generation of protectable intellectual property is not an essential requirement for this scheme; projects that will not generate patentable materials but that will nevertheless have the potential to provide health benefits are accepted on an equal basis. However, ownership and management of IP must be consistent with MRC s funding requirements. Projects with no plausible route to exploitation and ultimate health benefit or impact are extremely unlikely to be supportable. It is important that as much detail and evidence as possible is provided relating to ownership and exploitation of IP. For example, simply stating We have freedom to operate will generally not be considered sufficient. Note that unless otherwise indicated it will be assumed that the academic applicants will have the right to exploit the Knowledge developed by their activities at the end of the project. If the application involves an industrial partner, please refer to the MRC Industry Collaboration Agreement (MICA) webpage for further guidance or consult the relevant programme manager. Spinouts from academic institutions are considered to be separate, commercial, entities and background IP held by a spinout may be considered a barrier to downstream exploitation. Section 8: Project Duration and Cost Please include estimates of the duration and costs you anticipate will be required to reach each relevant checkpoint and any project partner contribution. The form will calculate the expected total project duration, cost and estimate the MRC contribution, based on 80% of the requested costs. Further guidance on Exceptions Costs can be found in the Outline Resource Summary section of Je-S and the MRC Applicants Handbook. Further guidance on NHS costs (excess treatment and NHS support costs) can similarly be found in MRC Applicants Handbook. Submitting the form Once completed, the Outline Case for Support Form should be saved as a PDF file and submitted via the Je-S system. Please note that your outline BMC: DPFS application will automatically be rejected if your Case for Support does not use the BMC: DPFS Outline Case for Support Form. Page 7

Using the Joint-electronic Submission System The Joint Electronic Submissions (Je-S) Helpdesk is the first point of contact for the Research Councils If you experience difficulties using Je-S or have questions regarding its use, the helpdesk can be contacted: Email: JeSHelp@rcuk.ac.uk Phone: +44 (0) 1793 44 4164* Staffed Monday to Friday 8.30am - 5pm (excluding bank holidays and other holidays) Out of hours: leave a Voice Mail message When reporting problems by e-mail or telephone, please supply the following information: Your name, organisation and user id The date and time The part of the form or system you were working on when the problem occurred The nature of the problem *Phone calls that cannot be answered during working hours will be redirected after 30 seconds to Voice Mail. The helpdesk will normally return your call within 3 hours. Classifications: Board or Panel Portfolio: Developmental Pathway Funding - DPFS Grant Type: Used for reporting purposes only, please select the option which best describes how you first heard about the BMC: DPFS scheme. Developmental Pathway & Clinical Studies (DPFS/DCS) or Biomedical Catalyst (BMC) Attachments: Select Add New Attachment: Applicants may submit PDF versions of: A cover letter including, if applicable, a response to Panel comments on a prior submission of the project (under document type Feedback Letter). The maximum length of a combined cover/feedback letter must not exceed 5 x A4 pages (Arial 11 point). In general succinct responses are encouraged and provision of information considered outside the scope of a cover/feedback letter will result in the application being returned for amendment. The BMC: DPFS Outline Case for Support Form (under document type Case for Support word limits not to be exceeded). An optional but advised document of supporting figures and data tables (under document type Supporting Data no more than 2 x A4 pages). Applicants seeking funding for hit-to-lead and lead optimisation projects must also complete the Small Molecule Supplementary Information form. This form can be downloaded via the BMC:DPFS website and should be uploaded to Je-S under document type Supporting Data. Where deemed necessary, failure to submit the form will result in your application being returned - please contact one of the relevant MRC Programme Managers if you have any queries; A CV for the Principal Investigator, any Co-Investigators and Named individual research staff, please refer to the Applicants handbook for further information on CV requirements (under document type CV - no more than 2 x A4 pages Arial 11 point). Page 8

A Publications list for the Principal Investigator, any Co-Investigators and Named individual research staff, please refer to the Applicants handbook for further information on publication requirements (under document type Publications - no more than 1 x A4 pages Arial 11 point). Optional letters of support from key collaborators or partners, such as industrial partners or clinical collaborators/recruiting centres (under document type Supporting Data no more than 2 x A4 pages per letter). Note the MRC reserves the right to decline or return an application on eligibility grounds, if documents other than those detailed above are submitted or if the guidance indicated above is not adhered to. Failure to follow the guidance may prejudice your application. Contacts If you have enquiries regarding the BMC: DPFS please contact one of the scheme programme managers. Contact details and scientific areas are available on the BMC: DPFS webpage. Page 9